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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, cell, automated (particle counter)
510(k) Number K981761
Device Name SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
Applicant
SYSMEX CORP.
ONE WILDLIFE WAY
LONG GROVE,  IL  60047 -9596
Applicant Contact NINA GAMPERLING
Correspondent
SYSMEX CORP.
ONE WILDLIFE WAY
LONG GROVE,  IL  60047 -9596
Correspondent Contact NINA GAMPERLING
Regulation Number864.5200
Classification Product Code
GKL  
Subsequent Product Code
GKZ  
Date Received05/19/1998
Decision Date 08/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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